Fluorodeoxyglucose -Positron Emission Tomography (FDG-PET) Based Radiotherapy Planning For Advanced Non-Small-Cell Lung Cancer (NSCLC) - Full Text View

Sponsored by:	Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN
Information provided by:	Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN
ClinicalTrials.gov Identifier:	NCT00697333

Purpose

Simultaneous radio-chemotherapy in advanced non-small cell lung cancer. The study focusses on a randomised comparison of conventional radiotherapy planning with irradiation of macroscopic tumor and lymph nodes together with prophylactic target volumes vs. irradiation only of FDG-positive lesions.

Primary endpoint is the local disease control in the chest.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Procedure: restriction of radiotherapy to FDG-PET positive areas only	Phase II

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Optimisation of Radiotherapy-Planning in Patients With Inoperable Locally Advanced Non-Small-Cell Lung Cancer by FDG-PET

Further study details as provided by Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN:

Primary Outcome Measures:

local progression free survival [ Time Frame: actuarial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Time Frame: actuarial ] [ Designated as safety issue: No ]
normal tissue toxicity [ Time Frame: actuarial ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	394
Study Start Date:	August 2008
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: No Intervention Irradiation of all tumor manifestations detectable by CT and/or FDG-PET including a part of eventual atelectasis and the whole affected lymph node stations by 60 - 74 Gy/2Gy) irradiation of elective lymph node stations up to 50 Gy/2 Gy
B: Experimental Irradiation of all tumor manifestations detectable by FDG-PET including the whole affected lymph node stations by 60 - 74 Gy/2Gy	Procedure: restriction of radiotherapy to FDG-PET positive areas only Restriction of target volumes to FDG-positive areas

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

histologically proved NSCLC
UICC-stage I-III, no resection planned
complete staging < 6 wks before treatment including cranial CT
ECOG <3, Karnofsky-Index >60%
age > 18 <
FEV1 > 1,0 l or >35%
RT-planning according to protocol feasible
chemotherapy feasible
written informed consent

Exclusion Criteria:

neuroendocrine tumors, plain broncho-alveolar-cell ca.
distant metastases, supraclavicular lymph node metastases
malignant pleural effusion
resection of actual tumor performed
inclusion in other study protocol
chemotherapy due to actual tumor before FDG-PET
induction-chemotherapy
acute vena cava superior syndrome
second malignancy other than basalioma
pregnancy, lactation
heart insufficiency NYHA III/IV
pneumoconiosis with active inflammatory changes of mediastinal lymph nodes
acute broncho-pulmonary infection at time of PET-examination

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697333

Contacts

Contact: U. Nestle, PD	49-684-1162 ext 2201	raunes@uks.eu
Contact: A. L. Grosu, PhD	49-761-270 ext 9461	anca.grosu@uniklinik-freiburg.de

Locations

Germany, Baden-Württemberg
Universitätsklinikum Freiburg
Freiburg i. Br., Baden-Württemberg, Germany, D-79106
Germany, Saarland
Universitätsklinikum des Saarlandes
Homburg/Saar, Saarland, Germany, D-66421

Sponsors and Collaborators

Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN

Investigators

Principal Investigator:

Ursula Nestle, PhD

Universitätsklinikum des Saarlandes, Homburg/Saar, Germany

More Information

German site of the working group conducting this study This link exits the ClinicalTrials.gov site

Publications:

Nestle U, Kremp S, Grosu AL. Practical integration of [18F]-FDG-PET and PET-CT in the planning of radiotherapy for non-small cell lung cancer (NSCLC): the technical basis, ICRU-target volumes, problems, perspectives. Radiother Oncol. 2006 Nov;81(2):209-25. Epub 2006 Oct 24. Review.

Nestle U, Schaefer-Schuler A, Kremp S, Groeschel A, Hellwig D, Rübe C, Kirsch CM. Target volume definition for 18F-FDG PET-positive lymph nodes in radiotherapy of patients with non-small cell lung cancer. Eur J Nucl Med Mol Imaging. 2007 Apr;34(4):453-62. Epub 2006 Oct 21.

Nestle U, Kremp S, Schaefer-Schuler A, Sebastian-Welsch C, Hellwig D, Rübe C, Kirsch CM. Comparison of different methods for delineation of 18F-FDG PET-positive tissue for target volume definition in radiotherapy of patients with non-Small cell lung cancer. J Nucl Med. 2005 Aug;46(8):1342-8.

Responsible Party:	Universitätsklinikum des Saarlandes ( PD Dr. Ursula Nestle )
Study ID Numbers:	AG NUK/RT 2006-1
Study First Received:	June 11, 2008
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00697333
Health Authority:	Germany: Ethics Commission

Keywords provided by Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN:

NSCLC
FDG-PET
Radiotherapy
planning
target volumes

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 15, 2009